Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-31 @ 7:14 PM
Study NCT ID:
NCT00360100
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2006-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010033', 'term': 'Otitis Media'}], 'ancestors': [{'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-16', 'studyFirstSubmitDate': '2006-08-02', 'studyFirstSubmitQcDate': '2006-08-02', 'lastUpdatePostDateStruct': {'date': '2011-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment-related vomiting on Day 1, which is based directly on the collected observed or voluntarily reported vomiting.'}], 'secondaryOutcomes': [{'measure': 'Time-to-vomiting (in minutes) will be measured for all vomiting episodes that occur within the 60-minute observation period post-dosing on Day 1.'}, {'measure': 'Frequency of the number of days of treatment-related vomiting by treatment group for subjects in the All Treated population.'}, {'measure': 'Frequencies of occurrence, by day, of treatment-related vomiting.'}, {'measure': 'Investigator and Sponsor assessment of clinical response.'}]}, 'conditionsModule': {'conditions': ['Otitis Media']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661170&StudyName=Zmax+Pediatric+Vs+Adult+Concentration+For+The+Treatment+Of+Acute+Otitis+Media++', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Assess tolerability of different dosing formulations (adult versus pediatric).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Months', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have clinical signs/symptoms of AOM in at least 1 ear\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity, or intolerance to azithromycin or other macrolides or to any penicillin, beta-lactam antibiotic or beta lactamase inhibitor\n* Previously diagnosed disease(s) of immune function\n* Treatment with any systemic (intravenous, intramuscular, oral) antibiotic for any indication within 7 days prior to enrollment'}, 'identificationModule': {'nctId': 'NCT00360100', 'briefTitle': 'Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomized, Multicenter, Comparative Study To Assess Tolerability Of A Single Oral 60 Mg/Kg Dose Of Zmax (Pediatric Concentration) Vs. Zmax (Adult Concentration) In Pediatric Patients With Acute Otitis Media', 'orgStudyIdInfo': {'id': 'A0661170'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Zmax', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bardstown', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.80923, 'lon': -85.4669}}, {'city': 'Springfield', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.68534, 'lon': -85.22218}}, {'city': 'Córdoba', 'state': 'Córdoba Province', 'country': 'Argentina', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'city': 'Santiago', 'state': 'RM', 'country': 'Chile', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Independencia', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -33.41167, 'lon': -70.66647}}, {'city': 'Providencia', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -33.43107, 'lon': -70.60454}}, {'city': 'San José', 'country': 'Costa Rica', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 9.93388, 'lon': -84.08489}}, {'city': 'Santo Domingo', 'state': 'DN', 'country': 'Dominican Republic', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}, {'city': 'Guatemala City', 'country': 'Guatemala', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}, {'city': 'Panama City', 'country': 'Panama', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer'}}}}